技術轉讓

諾孚泰制劑技術轉讓和歐洲批文轉讓服務介紹
Introduction of Tech transfer and MA transfer

2015排列三走势图带连 www.umtld.icu 諾孚泰制劑技術轉讓和歐洲批文轉讓服務介紹

Introduction of Tech transfer and MA transfer

 

1. 關于我們 ABOUT US

廣州安信已在中國進行原料藥注冊及分銷接近10年,企業數據庫覆蓋逾400家客戶,經驗豐富。著眼于客戶需求,2017年,安信成立子公司廣州諾孚泰醫藥科技有限公司,為客戶提供制劑相關的服務,包括制劑引進、技術引進、咨詢及注冊服務。

Guangzhou Greensyn have been engaged in registration and distribution of API for nearly 10 years in China. Which cooperates to more than 400 clients with rich experience. Greensyn Lifescience Co., Ltd, as one subsidiary of Greensyn is established in 2017, its major business to provide FDF services related to FDF Licensing-in, FDF tech-transfer and, consultation and registration services.

 

 

2. 背景 Background

2016年,國家食品藥品監督管理局(CFDA)轉發國務院發布的《關于開展仿制藥質量和療效一致性評價的意見》,仿制藥一致性評價正式拉開大幕。通知要求2018年底前,289種成品劑量必須通過仿制藥質量一致性評估。

In 2016, CFDA announced Opinions on the Quality and Efficacy Consistency Evaluation of Generic Drugs, which requires that there are 289 kinds generic drugs have to attach the standard of the quality and efficacy consistency evaluation before end of 2018.

 

2018年7月10日,國家藥品監督管理局發布了《接受藥品境外臨床試驗數據的技術指導原則》的通告(2018年第52號)。該指導原則所涉及的境外臨床試驗數據,包括申請人通過創新藥的境內外同步研發在境外獲得的臨床試驗數據,以及具備完整可評價的生物等效性數據的在境外開展仿制藥研發。

就目前情況看來,國家法規開始認可接受國外的臨床數據,這將對從國外引進優質的制劑和技術產生非?;撓跋?。

On July 10, 2018, the CFDA issued the notice Technical Guidelines for Accepting Data from Clinical Trials Outside the Territory of Drugs (no. 52 of 2018). The guideline covers overseas clinical trial data, including the clinical trial data obtained by the applicant through synchronous research and development of innovative drugs in and out of China, and the research and development of generic drugs in foreign countries with complete and evaluable bioequivalence data.

it is a good time for domestic pharmaceuticals companies to license generic drugs and/or transfer formulations from foreign supplier during this special period.

 

 

3. 合作優勢 Advantages

1) 諾孚泰的國際資源豐富。目前,我們已經和國外超過40家優秀藥企進行了長期的合作,能提供超過150個品種的制劑技術,對應超過30種適應癥。

Supporting by huge and various international pharmaceutical companies, Greensyn are available a lot of high quality FDF to meet the need of domestic customers. So far, Greensyn Lifescience has cooperated to more than 40 excellent pharmaceutical companies abroad, among more than 150 kinds of FDF with mature technology, referring to more than 30 therapeutic fields.

 

2) 技術資料包括完整的CMC資料和正式的生物等效數據,同時還包括商業批次生產的相關數據及記錄,轉移技術時可以進行有效的數據重現,減少研發資金和時間成本的投入并快速完成技術落地。

FDF dossier including complete CMC materials, formal BE data, related date and report of business batch manufacture, could be effectively reproduce technology, which reduces the cost of development and saves time, and could finish tech transfer quickly.

 

3) 同時,供應商還會根據客戶的需要進行線上或現場的技術指導,這能極大程度的保證技術落地

Supplies will provide technical support with on-site and/or on-line assistance to help customers until success to tech transfer.

 

4) 結合技術提供方的經驗,還能有效幫助客戶生產場地快速獲得歐洲GMP資質,提高整體質量,為走國際化道路作鋪墊
Clients’ manufacture site could be rapidly approved by EU GMP qualification under foreign supplies’ support with mature development experience. It is helpful for domestic customers to explore international market.

 

4. 合作附加價值 Package Service

1) 開展技術引進合作,客戶可根據需要購買歐洲上市批文,用以觸發GMP審計或在上市地進行銷售;
Customers could purchase EU MA by supplier if need, to sale drug in territory 

2) 安信旗下子公司還可提供以下服務:
Greensyn and its other subsidiary also provide following service to our clients:

a) 國外優質API的中國穩定供貨 High-quality API supply to domestic customers.

b) 輔助進行API、藥用輔料及藥用包材的備案。Assist to file API, excipients and medical packaging materials.

c) 中國及歐美法規咨詢服務等。
consult Law and Regulation referring to drug registration and other related business at home and aboard.


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